Methods for the minimally invasive treatment of urinary stones

ABSTRACT

Methods using a small outer diameter ureteroscope may help overcome many of the problems associated with the prior art devices and methods for removing kidney stones. The ureteroscope includes an elongate member having a distal portion, a proximal portion, and an inner conduit that extends longitudinally between the proximal and distal portions. The elongate member is made from a passively flexible material that is capable of being inserted and directed through a patient&#39;s body cavity, such as the ureter, by manual direction and pressure so that minimal, if any, additional mechanical or steering mechanisms are present. An imaging device and light source are provided at the distal portion of the elongate member to allow for positioning the device with respect to the stone. A laser fiber can be directed through the conduit to destroy a targeted stone.

RELATED APPLICATION

This application is a divisional application of U.S. patent applicationSer. No. 13/827,045 filed Mar. 14, 2013, the contents of which arehereby incorporated by reference as if recited in full herein.

FIELD

The present invention relates generally to devices and associatedmethods for the removal of urinary stones from a body cavity, and inparticular, to devices and associated methods for removal of urinarystones as a truly outpatient procedure(non-hospital or office).

BACKGROUND

Kidney stones, which are also commonly known as urinary stones, aresolid accumulations and aggregations of matter formed in the kidneysfrom minerals in the urine.

Urinary stones are typically classified by their location in the kidney,ureter, or bladder, or by their chemical composition. About 66% of thosewith kidney stones are men.

Kidney stones typically leave the body by passage in the urine stream,and many stones are formed and passed without causing symptoms. Ifstones grow to sufficient size (usually at least 3 millimeters (0.12in)) they can cause obstruction of the ureter. Ureteral obstruction hasmany adverse side effects including discomfort, pain, and spasm of theureter. In many cases, the pain is commonly felt in the flank (the areabetween the ribs and hip), lower abdomen, and groin (a condition calledrenal colic). In some instances, renal colic can be associated withnausea, vomiting, fever, blood in the urine, pus in the urine, andpainful urination.

Currently, there are three primary treatment options that account forover 99% of the surgical treatments of kidney stones: 1) percutaneousnephrolithotomy (PNL), 2) shock wave lithotripsy (SWL), and 3)ureteroscopic stone removal (URS).

PNL is generally used for stones larger than about 20 mm in diameter,and is performed almost exclusively for large stones within the kidneys.SWL is generally used to treat moderate sized stones, for example,stones having diameters ranging from 5 to 20 mm. URS is commonly usedfor stones having diameters of less than 20 mm. While PNL is usedexclusively in the kidneys, SWL and URS can be used to treat kidneystones in the kidney and the ureter.

In addition to the above techniques, medical expulsion therapy (MET)employs medications to assist in the natural passage of the stone. METmay improve the statistical likelihood of small stone (2-6 mm) passageprovided the patient remains comfortable and stable.

However, this may require days to weeks of observation in an outpatientmode, waiting with uncertainty for a stone to pass. In the event thestone fails to pass, the patient will often require an operativetreatment using URS or SWL. To date, no medications exist to dissolvestones, and stones 7 mm diameter or greater have less than 10% chance ofpassage.

SWL and URS are both typically outpatient procedures, as opposed to PNL,which requires a hospitalization of 1-2 days after surgery. SWL istypically performed with intravenous sedation (no formal anesthesia)with no instrumentation inserted into the patient. However, successrates, defined as stone-free with a single treatment session, generallydo not exceed 75%. SWL typically depends on the availability of anexpensive mobile machine that is rarely hospital owned, traveling aroundon a scheduled circuit, typically once weekly for most hospitals.

In contrast, URS is performed in the hospital operating room almostalways with general anesthesia. URS is normally available on a daily24/7 basis, with the insertion of a small fiberoptic telescope into thepatient through the natural urinary channels (no incisions). Thetelescope is advanced up the ureter to the stone, where, if small enough(2-5 mm), it may be extracted intact. Otherwise the stone is fragmentedin place with a laser fiber passed through the telescope. Fragments arethen irrigated out or extracted mechanically with miniature instruments.Success or stone free rates for URS are 95-98% in experienced hands.

Due to the outpatient scheduling requirement for SWL, patient selectionmust be limited to those whose pain is well controlled and who have noother relatively common co-existent emergent contraindications that astone may present, such as infection or kidney failure. Thesecomplicating factors demand a more urgent intervention than SWL canprovide.

Unfortunately, there are currently no surgical treatments that areavailable as an outpatient in the urologist's office. Each of the abovetechniques requires formal sedation or anesthesia and the support ofin-hospital environment (URS) or mobile lithotripsy unit (SWL). Both ofthese treatments also require the use of radiologic support in the formof fluoroscopy to monitor the treatment and technical progress duringthe procedure.

The relative status quo of the above surgical techniques for urologicstone disease has been the case now for approximately 15 years in theU.S. There have been no significant technological changes in PNL or SWLtechnology in over 20 years and no new advances are advertised oranticipated from known current research efforts. The most recentinnovations in the triad of stone surgery occurred with URS, with theintroduction of the first miniaturized flexible ureteroscope around1995.

However, current ureteroscopes generally include a requisite mechanicalstructure so that they can be actively steered and directed through theureter to the location of the stone, and into the kidney where activesteerability of the ureteroscope is mandatory. As a consequence, thesizes of these ureteroscopes have been limited to minimum diametersranging from 2.5 to 3.0 mm diameter (7.5-9 F). Currently, no passivelyflexible exists exclusively for ureteral stone surgery.

Current ureteroscopes rely on the use of laser lithotripsy to destroystones by passing a tiny laser fiber through a channel within thetelescope. The laser fiber transmits laser energy from a separate lasersource located in proximity to the surgical field. The laser fiber thenis placed in contact with a stone under direct vision and the surgeonreduces the stone to dust and tiny passable fragments. The ureteroscopeis removed and the patient awakens, goes to a recovery nursing unit andis discharged home. The sizes of current ureteroscopes are such that thetechnique of introduction and manipulation would not be tolerated by anun-anesthetized patient.

Accordingly, there still exists a need for devices and associatedmethods that can be used to remove urinary stones as a truly outpatientprocedure that can be performed in a non-hospital, office environment.

SUMMARY

Embodiments of the present invention are directed to passively flexibleureteroscopes having diameters of less than about 2.5 millimeters (mm),and in particular is about 2 mm or less. As a result, devices inaccordance with embodiments of the present invention may help overcomemany of the problems associated with the prior art devices and methodsfor removing kidney stones. In particular, the availability tosurgically treat patients suffering from kidney stones as anon-hospital, truly outpatient procedure may help minimize patient painand suffering as well as significantly reduce costs typically associatedwith the surgical treatment of kidney stones.

In one embodiment, the present invention is directed to a device forremoving a stone from a body cavity comprising an elongate member havinga distal portion, a proximal portion, and an inner conduit that extendslongitudinally between the proximal and distal portions. The elongatemember comprises a passively flexible material that is capable of beinginserted and directed through a patient's body cavity, such as theureter, by manual direction and pressure so that minimal, if any,additional mechanical or steering mechanisms are present. As a result,the diameter of the elongate member can be significantly reduced incomparison to convention ureteroscopes, which in turn, may permit thesurgeon to surgically remover kidney stones from the ureter in a trulyoutpatient process. That is, without the need for hospitalization andanesthetization of the patient.

Suitable materials for the elongate member may include a wide variety ofpolymers including silicone rubber, nitinol, nylon, polyurethane, andpolyethylene terephthalate (PETE) latex, polytetrafluoroethylene(TEFLON®), hydrophilic polymers, and thermoplastic elastomers. In oneparticular embodiment, the elongate member comprises a flexible siliconematerial. wherein the elongate member is passively flexible and has adiameter that is less than about 2.5 mm.

In one embodiment, the device also includes a port disposed towards theproximal portion of the elongate member and an opening disposed at thedistal portion of the elongate member. The port and opening are incommunication with each other via the conduit. The conduit, whichfunctions as a working channel, can be used to introduce variousdevices, such as an irrigation tube, laser fiber, basket, and the like,into a desired location with respect to a targeted kidney stone. In oneembodiment, the optical device comprises a charged coupled device orfiber optics.

In addition, the device includes an optical device disposed towards theproximal portion of the elongate member, and at least one light sourcedisposed towards the proximal portion of the elongate member. Theoptical device and the light source cooperate to provide the surgeonimages of the stone so that the laser fiber can be properly positionedand the surgeon can monitor the status of the procedure.

In some embodiments, the elongate member may include an outer coatingcomprising a hydrophilic material, such as polyurethane.

In a further aspect, the invention is directed to a method of removing akidney stone from a patient in need thereof, the method comprising thesteps of: inserting a cystoscope into a bladder of a patient;identifying a kidney stone in a ureter of the patient; positioning aguidewire in close proximity to the stone; providing a ureteroscope inaccordance with at least one embodiment of the present invention;traveling the ureteroscope over the guidewire to position theureteroscope in close proximity to the stone; removing the guidewire;obtaining an image of the ureter with the optical device of theureteroscope; positioning the ureteroscope so that a center of mass ofthe stone is centered in the image; passing a laser fiber through theureteroscope so that the laser fiber is in close proximity to the stone;activating the laser fiber to fragment the stone.

In some embodiments, the step of identifying the kidney stone may beperformed with the assistance of an imaging procedure, such asfluoroscopic imaging.

Aspects of the present invention may provide advantages over currentlyavailable treatment methods for the treatment of kidneys stones. Inparticular, the availability to surgically treat patients suffering fromkidney stones as a non-hospital, truly outpatient procedure may helpminimize patient pain and suffering as well as significantly reducecosts typically associated with the surgical treatment of kidney stones.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

Having thus described the invention in general terms, reference will nowbe made to the accompanying drawings, which are not necessarily drawn toscale, and wherein:

FIG. 1 is a side view of a device in accordance with at least oneembodiment of the present invention;

FIG. 2A is a partial side view of the distal portion of the device ofFIG. 1;

FIG. 2B is a front view of the distal portion of the device of FIG. 1;and

FIG. 3 is a partial side view on alternative embodiment of the device ofFIG. 1.

DETAILED DESCRIPTION

The present invention now will be described more fully hereinafter withreference to the accompanying drawings, in which some, but not allembodiments of the inventions are shown. Indeed, these inventions may beembodied in many different forms and should not be construed as limitedto the embodiments set forth herein; rather, these embodiments areprovided so that this disclosure will satisfy applicable legalrequirements. Like numbers refer to like elements throughout.

With reference to FIG. 1, a device for removing a stone from a bodycavity that is in accordance with at least one embodiment of the presentinvention is illustrated and designated with reference number 10. Thedevice 10 comprises an elongate member 12 having a distal portion 14 anda proximal portion 16. The interior of the elongate member 12 includes alongitudinally extending conduit 18 (represented by the dashed lines inFIG. 1) that extends from a port 20 located towards the proximal portion16 of the elongate member 12 and an opening 22 disposed at the distalportion 14 of the elongate member 12. The conduit is configured toprovide communication between the port and the opening.

The elongate member comprises a passively flexible material so that thedevice can be inserted and directed through a patient's body cavity,such as the ureter, with minimal, if any, additional mechanical orsteering mechanisms that are present in conventional ureteroscopes andcystoscopies. In other words, the term passively flexible means that theelongate material has sufficient flexibility so that it can bemaneuvered through the ureter, or other body cavity, without the needfor additional steering devices or associated mechanical structures. Asa result, the diameter of the elongate member can be significantlyreduced in comparison to conventional ureteroscopes. Suitable materialsfor the elongate member may include a wide variety of polymers includingsilicone rubber, nitinol, nylon, polyurethane, and polyethyleneterephthalate (PETE) latex, polytetrafluoroethylene (TEFLON®),hydrophilic polymers, and thermoplastic elastomers. In one particularembodiment, the elongate member comprises a flexible silicone material.It should be recognized that in some embodiments, the elongate membermay include some minimal steering devices and associated structuresprovided that the minimal size and flexibility of the device ismaintained.

Turning now to FIGS. 2A and 2B, a partial view of the elongate member isshown. As shown in FIG. 2A, the diameter D1 (or width) of the elongatemember is generally less than about 2.5 millimeters (mm), and inparticular is about 2 mm or less. In some embodiments, the diameter Dlis from about 1.7 to 2.2 mm, and more particularly, about 2 mm.

The diameter D2 (or width) of the conduit 18 is desirably large enoughto allow for irrigation as well as the insertion of a guide wire orlaser fiber. In some embodiments, the diameter D2 is less than 1.25 mm,and preferably less than about 1 mm, and more preferably, about 0.7 to 1mm, with a size of about 1 mm being most preferred.

The overall length of the elongate member is desirably sufficient sothat it can be inserted and directed to a desired location in a bodycavity. For example, in applications directed to the removal of a kidneystone in the ureter, the length of the elongate member may range fromabout 35 to 55 centimeters (cm), and in particular, about 40 to 45 cm.

The distal portion of the elongate member defines a tip portion 24 ofthe device in which an optical device 26, such as a charged coupleddevice (CCD), camera, or optical fiber, and a light source 28 ispositioned. In this regard, FIG. 2B shows a front view of the medicaldevice 10 in which the light source 28 and optical device 26 arepositioned in the tip portion 24 of the elongate member. The opticaldevice and light source will typically be connected to an external powersource, control device (e.g., a processor) via one or more connectors,such as wires, that extend through one or more additional conduits (notshown) that extend longitudinally through the elongate member.

In the illustrated embodiment, the light source and optical device areshown as being disposed above the opening 22 to the conduit. However, itshould be recognized that other configurations may be utilized in thepractice of the invention. As shown in FIG. 2A, the overall diameter D3(or width) of the optical device may be about 1 to 1.5 mm, and inparticular, about 1.1 to 1.3 mm. Preferably, the diameter D3 is about1.2 mm or less.

The optical device 26 is generally positioned such that it is locatedfor enabling imaging of forward regions of the body cavity in which thedevice is positioned. In one embodiment, optical device may be arrangedfor focusing incident light onto a CCD for generation of a signal whichis communicated to an external display, for example a monitor,television or the like. The signal provided by the optical device ispreferably digital, although other formats such as analogue signals maybe used. In one embodiment, the signal is communicated to the display byconductors such as electrical wires or an optical fiber carrying amodulated signal.

Other embodiments may include wireless transmission means, for example aminiature radio transmitter, which is adapted to receive a signal fromthe optical device and transmit the signal through the body of thepatient to a receiver located externally of the patient. This embodimentadvantageously dispenses with the requirement for electrical conductorsto connect the optical device to a display. In still other embodiments,the device may include a transmitter positioned towards a proximalportion of the device, such as in a handle, so that the signal can betransmitted from the transmitter to the display, such as through a radiotransceiver or similar device. In this embodiment, the optical devicemay be connected to the transmitter through conductors, such aselectrical wires.

In some embodiments, the optical device may comprise an optical fiber.In particular, visualization within the body cavity may be achievedutilizing one or more optic fibers arranged in the same manner as theelectrical conductors associated with a CCD. Preferably, a bundle ofoptic fibers will be used. Generally, the optic fibers will terminate atthe distal tip of the elongate member. In one embodiment, the distalends of the optical fibers are arranged with one or more lenses held inthe casing, for feeding light incident upon the lens into the fibers.The light is transmitted by means of internal reflection along thelength of the optical fiber to proximal ends. Light processing means,such as processor, disposed at the proximal ends of the optical fibersreceive the light and derive therefrom an image for display upon thedisplay device in a manner known to those skilled in the art.

The light source is preferably disposed proximate the optical device, oris integral therewith, so as to illuminate the region of the body cavityto be imaged. In exemplary embodiments the light source takes the formof a miniature globe, a diode, or for instance an optical fiberpositioned so as to communicate light from an external light source. Inthe case of optical fibers, the size of a bundle of optical fibers maygenerally have a diameter from about 0.25 to 0.6 mm and, in particular,from about 0.4 to 0.5 mm.

Referring back to FIG. 1, the device 10 may include a handle 32 disposedtowards the proximal end of the elongate member. The handle may alsoinclude an inlet/outlet 34 for one or more conductors, such as wires,for providing power and communications to the light source and opticaldevice. In an alternative embodiment, the handle may include a powersource, such as a battery, and a transceiver for facilitating wirelesscommunication between the optical device and an external display device.

In one embodiment, the outer surface 36 of the elongate member mayinclude an outer sheath, such as a polymeric coating, that substantiallycovers the outer surface of the elongate member. In one embodiment, thesheath may comprise a polymer coating including but not limited to suchsubstances as polyurethane (e.g., polyurethane 55D and 90A) orpolytetrafluoroethylene, or silicone. In a preferred embodiment, thesheath includes a hydrophilic coating.

As noted previously, the conduit 18 is desirably large enough to allowfor irrigation as well as the insertion of a guide wire or laser fiber.In particular, the conduit also commonly referred to as a “workingchannel” provides a means through which the body cavity can be irrigatedvia a saline or similar solution, and means for positioning a laserfiber in close proximity to a stone to be targeted for removal. The port20 through which access to the conduit is obtained, can be anyconventional port, such as a standard Luer-lok. In one embodiment, anirrigation tubing can be introduced into the conduit via the port.

In some embodiments, the distal portion of the elongate member may beslightly angled so as to provide better maneuvering and positioning ofthe medical device within the body cavity. In this regard, FIG. 3illustrates an embodiment of the invention in which the distal portionof the elongate member includes an angled portion 40 that is slightlyangled relative to the remaining portion of the elongate member. Asshown in FIG. 3 the angle defined by the angled portion is identified asangle α. Angle α can generally range from about 3° to 8°, and inparticular is about 5°. With rotational manipulation of the slightlyangled tip, the tip may be directed in a 360° fashion to address a stonein the lumen of the ureter.

Advantageously, medical devices in accordance with the present inventioncan be used to treat patients suffering from kidney stones of less than20 mm. As a result, the invention may help avoid problems associatedwith prior treatment methods that typically require hospitalization.

In a typical procedure according to the present invention, the patientundergoes conscious sedation (with or without supplemental oralsedation) while in the supine position (male patient) or lithotomyposition (female patient). Initial endoscopy on the patient is thenperformed with a standard flexible cystoscope, also using local gelanesthesia as per standard current outpatient or office protocol. Thecystoscope is advanced per urethra into the bladder and the bladder isinspected. The location of the stone within the ureter is identified andconfirmed. Preferably, the location is confirmed by pre-proceduralimaging.

In some embodiments, it may also be desirable to perform this part ofthe procedure with the assistance of fluoroscopic imaging. Radiographic(fluoroscopic) study of the involved ureter may be performed by thegentle retrograde injection of contrast into the ureteral orifice in thebladder through a standard ureteral catheter, such as a 5F catheter(retrograde ureterogram).

After the stone has been located and identified, a guidewire is advancedthrough the working channel of the cystoscope. In one particularembodiment, the guidewire (e.g., a standard GLIDEWIRE®) may be advancedthrough the previously inserted catheter. Preferably the guidewire is astandard 0.035″ or less (e.g., from 0.025″-0.035″) hydrophilicguidewire. Once the guidewire is positioned in the desired locationrelative to the stone, the catheter is removed leaving the guidewire inplace. In an alternative embodiment, the cystoscope may also be removedat this time.

The device 10 (also referred to herein as a ureteroscope) is now passedover the guidewire and into the bladder and up the ureter until thestone is encountered. In a preferred embodiment, positioning of theureteroscope is assisted with fluoroscopic imaging. The guidewire is nowremoved and irrigation (normal saline) is initiated through the conduitof the ureteroscope.

The ureteroscope may be now be manipulated either forward or backward bythe surgeon's hand. Rotational manipulation may be achieved by the useof a modified torque device (e.g., Cook Urological) applied to theureteroscope. The optical device of the ureteroscope can now be used toobtain images of the patient's ureter with the assistance of the lightsource. As noted previously, the optical device is configured to provideimages via a display device.

By a combination of longitudinal and rotational manipulation, the stonewill be engaged in a “center of mass” view. Once a satisfactory “sightpicture” is achieved with the optical device wherein the stone iscentered in view, a laser fiber (e.g., standard 270 micron holmium laserfiber) will be passed through the conduit of the ureteroscope. With thelaser fiber in direct contact with the stone, the laser is activated andfired at standard energy settings (typically 6-10 Hz at 600-800 mJ).Once the stone is fragmented sufficiently, the laser will bediscontinued and removed from the ureteroscope. Stone fragments may becleared by passage of a 1.9F stone basket through the conduit andwithdrawing the fragments into the bladder. At this point, theureteroscope can be removed from within the patient.

In a further aspect of the invention, a ureteral stent (6F) can bepositioned in the patient's ureter. In this aspect, (the cystoscope isreintroduced if previously removed) and a guidewire is then passed intothe ureter under fluoroscopic imaging. The guidewire is then advanced tothe level of the kidney. A ureteral stent (6F) is then passed over theguidewire until a proximal end of the stent is in the kidney, and adistal end of the stent remains in the bladder. At this point thecystoscope is removed and the procedure is completed.

Generally, it may be desirable to monitor the patient in a holding areafor up to one hour and discharged home to follow-up in one week. Thestent ensures that the ureter remains patent in the post-procedureperiod until the patient returns to the office for follow-up. This istypically after one week for a brief removal of the stent in similarfashion using the cystoscope, requiring only local topical gelanesthesia.

From the foregoing discussion, it is evident that the present inventionprovides many advantages over currently available treatment methods forthe treatment of kidneys stones. In particular, the availability tosurgically treat patients suffering from kidney stones as anon-hospital, truly outpatient procedure may help minimize patient painand suffering as well as significantly reduce costs typically associatedwith the surgical treatment of kidney stones.

Many modifications and other embodiments of the inventions set forthherein will come to mind to one skilled in the art to which theseinventions pertain having the benefit of the teachings presented in theforegoing descriptions and the associated drawings. Therefore, it is tobe understood that the inventions are not to be limited to the specificembodiments disclosed and that modifications and other embodiments areintended to be included within the scope of the appended claims.Although specific terms are employed herein, they are used in a genericand descriptive sense only and not for purposes of limitation.

That which is claimed:
 1. A method of removing a kidney stone from apatient in need thereof, the method comprising: inserting a cystoscopeinto a bladder of a patient; identifying a kidney stone in a ureter ofthe patient; positioning a guidewire in close proximity to the stone;providing a ureteroscope with an elongate member having a distal portionand an opposing proximal portion with a longitudinally extending conduitextending through an interior of the elongate member, wherein theelongate member has a maximal outer diameter that is 2.0 mm or less overa length extending between the proximal portion and the distal portion;traveling the conduit of the ureteroscope over the guidewire to positionthe distal portion of the elongate member of the ureteroscope in closeproximity to the stone; removing the guidewire; obtaining an image ofthe ureter with an optical device of the ureteroscope; positioning theureteroscope so that a center of mass of the stone is centered in theimage; passing a laser fiber through the conduit of the ureteroscope sothat the laser fiber is in close proximity to or directly contacts thestone; and activating a laser in communication with the laser fiber tofragment the stone.
 2. The method of claim 1, wherein the method iscarried out in an outpatient non-hospital environment without the needfor general anesthesia.
 3. The method of claim 1, wherein the travelingand/or positioning of the ureteroscope comprises longitudinally androtationally manipulating the ureteroscope, wherein the method furthercomprises removing the laser fiber from the conduit of the ureteroscopeafter the stone is fragmented, then passing a stone basket through theconduit and withdrawing the fragments into a bladder of the patient,then removing the ureteroscope from the patient.
 4. The method of claim1, further comprising removing the cystoscope from the patient once theguidewire is in position before traveling the ureteroscope to the stone.5. The method of claim 1, wherein the conduit defines a single workingchannel of the ureteroscope and extends to an external port proximatethe proximal portion of the elongate member, and wherein the method iscarried out to serially first introduce the guidewire, then the laser,then dispense liquid all via the port of the conduit.
 6. The method ofclaim 1, wherein the distal portion of the elongate member has adistalmost tip and the conduit channel terminates a distance behind thetip, wherein the tip holds the optical device and at least one lightsource, and wherein the image is obtained while illuminating the stoneusing the at least one light source.
 7. The method of claim 6, whereinthe at least one light source includes first and second light sourcesarranged with the optical device therebetween.
 8. The method of claim 1,wherein the elongate member maximal outer diameter is under 2.0 mm toabout 1.7 mm over a length of between 35-55 centimeters between theproximal and distal portions.
 9. The method of claim 7, wherein thelight sources comprise optical fibers, wherein the conduit is a singleworking channel of the ureteroscope and has a diameter of 1.25 mm orless, and wherein the optical device has a diameter between 1 mm to 1.5mm.
 10. The method of claim 1, wherein the maximal outer diameter of theelongate member extends for a length of between 35-55 centimetersbetween the proximal and distal portions.
 11. A method of removing akidney stone from a patient in need thereof, the method comprising:providing a ureteroscope with a single working channel in an elongatemember having a distal portion and an opposing proximal portion with alongitudinally extending working channel extending through an interiorof the elongate member between an external port and an open distal end,wherein the elongate member has a maximal outer diameter that is 2.0 mmor less over a length extending between the proximal portion and thedistal portion , and wherein the maximal outer diameter of the elongatemember extends for a length of between 35-55 centimeters between theproximal and distal portions; inserting a cystoscope into a bladder of apatient; identifying a kidney stone in a ureter of the patient;positioning a guidewire in close proximity to the stone; guiding theureteroscope over the guidewire to position the distal portion of theelongate member of the ureteroscope in close proximity to the stone;obtaining an image of the ureter with an optical device held by theureteroscope; passing a laser fiber through the working channel of theureteroscope to a target treatment site so that the laser fiber is inclose proximity to or directly contacts the stone; activating a laser incommunication with the laser fiber to fragment the stone while the laserfiber is in close proximity to or directly contacts the stone; andirrigating the target treatment site by introducing irrigation liquidinto the port and through the working channel.
 12. The method of claim11, wherein the inserting, identifying, positioning, guiding, removing,obtaining, passing, activating and irrigating steps are carried out inan outpatient facility without general anesthesia.
 13. The method ofclaim 11, wherein the guiding of the ureteroscope compriseslongitudinally and rotationally manipulating the ureteroscope.
 14. Themethod of claim 11, wherein the method further comprises: removing theguidewire from the working channel before passing the laser fiberthrough the working channel; removing the laser fiber from the workingchannel of the ureteroscope after the stone is fragmented; then passinga stone basket through the working channel and withdrawing the fragmentsinto a bladder of the patient; and then removing the ureteroscope fromthe patient after the irrigation.
 15. The method of claim 11, furthercomprising removing the cystoscope from the patient once the guidewireis in position before guiding the ureteroscope to the stone.
 16. Themethod of claim 11, wherein the distal portion of the elongate memberhas a distalmost tip and the working channel terminates a distancebehind the tip, wherein the tip holds the optical device and at leastone light source, and wherein the image is obtained while illuminatingthe stone using the at least one light source.
 17. The method of claim16, wherein the at least one light source includes first and secondlight sources arranged with the optical device therebetween.
 18. Themethod of claim 11, wherein the elongate member maximal outer diameteris under 2.0 mm to about 1.7 mm over a length of between 35-55centimeters between the proximal and distal portions.
 19. The method ofclaim 11, further comprising illuminating the target treatment site withat least one light source held by the distal end portion of theureteroscope.
 20. The method of claim 19, wherein the working channelhas a diameter of 1.25 mm or less, and wherein the optical device has adiameter between 1 mm to 1.5 mm.